Second Source Manufacturer Sample Clauses
Second Source Manufacturer. Customer may in its discretion appoint a second source to manufacture one or more of the Products. Manufacturer will provide Customer reasonable cooperation as necessary to enable manufacturing by the second source of the applicable Product(s), including informing Customer promptly of any future changes in the design or ▇▇▇▇ of materials for the Product. In addition, to the extent Manufacturer or a Manufacturer affiliate produces any [*], Manufacturer agrees to [*] on a timely basis at [*] the [*] as stated on Manufacturer’s ▇▇▇▇ of materials provided to Customer for the applicable Product [*]. * Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Second Source Manufacturer. 3.6.1 BI RCV acknowledges that it is critical that VIDARA be ensured continuity of supply of PRODUCT for use in clinical trials and market supply. BI RCV shall ensure continuity of supply of PRODUCT for use in clinical trials and market supply. Nevertheless, due to the potentially growing market demand of PRODUCT, BI RCV’s ability to manufacture and supply PRODUCT shall be carefully observed. Should at any time BI RCV have any indication that continuity of supply can not be ensured, BI RCV shall immediately inform VIDARA thereof in writing. In this event the matter would be immediately forwarded to the STEERING COMMITTEE to discuss second source manufacture of PRODUCT reasonably and in good faith.
3.6.2 In the event the STEERING COMMITTEE decides that it is appropriate for VIDARA to establish a second source manufacturer, VIDARA agrees to provide the first opportunity to qualify as a second source manufacturer for PRODUCT to a BI RCV AFFILIATE. If such an AFFILIATE is – as foreseeable – unable to supply VIDARA’s PRODUCT requirements then VIDARA shall be free to choose an alternate supplier. In this case BI RCV shall assist VIDARA in transferring the MANUFACTURING PROCESS to a third party supplier by providing reasonable technical assistance and documentation as necessary for a transfer to a party well skilled in the manufacture of such biotech products at VIDARA’s cost.
3.6.3 In addition, the parties, through the STEERING COMMITTEE shall work together in good faith to develop a risk mitigation plan to minimise any risk of interruption in the supply of PRODUCT for use in clinical trials and market supply, which plan may include, among other things, production of excess PRODUCT or materials relating thereto (e.g., BBS) that can be used as a buffer and/or the off-site storage of certain PRODUCT or materials relating thereto.
Second Source Manufacturer. 3.7.1 BI Austria acknowledges that it is critical that InterMune be ensured continuity of supply of PRODUCT for use in clinical trials and market supply. BI Austria shall ensure continuity of supply of PRODUCT for use in clinical trials and market supply. Nevertheless, due to the potentially growing market demand of PRODUCT, BI Austria’s ability to manufacture and supply PRODUCT shall be carefully observed. Should at any time BI Austria have any indication that continuity of supply can not be ensured, BI Austria shall immediately inform InterMune thereof in writing. In this event the matter would be immediately forwarded to the STEERING COMMITTEE to discuss second source manufacture of PRODUCT reasonably and in good faith.
3.7.2 In the event the STEERING COMMITTEE decides that it is appropriate for InterMune to establish a second source manufacturer, InterMune agrees to provide the first opportunity to qualify as a second source manufacturer for PRODUCT to a BI Austria AFFILIATE. If such an AFFILIATE is – as foreseeable — unable to supply InterMune’s PRODUCT requirements then InterMune shall be free to choose an alternate supplier. In this case BI Austria shall assist InterMune in transferring the MANUFACTURING PROCESS to a third party supplier by providing reasonable technical assistance and documentation as necessary for a transfer to a party well skilled in the manufacture of such biotech products at InterMune’s cost.
3.7.3 In addition, the parties, through the STEERING COMMITTEE shall work together in good faith to develop a risk mitigation plan to minimize any risk of interruption in the supply of PRODUCT for use in clinical trials and market supply, which plan may include, among other things, production of excess PRODUCT or materials relating thereto (e.g., BBS) that can be used as a buffer and/or the off-site storage of certain PRODUCT or materials relating thereto.
Second Source Manufacturer. ONCOVIR has identified [* * *] potential additional manufacturing sites for Product, and within [* * *] of the effective date of this agreement, ONCOVIR will take all reasonably necessary steps to validate one such additional manufacturing sites capability to manufacture the Product (including, without limitation, in Bulk Product and Finished Dosage Form) (“Second Source Manufacturer”) that complies with all Applicable Laws and is qualified to manufacture the Product in compliance with Regulatory Requirements. ONCOVIR will transfer its manufacturing method details and trade secrets directly to the Second Source Manufacturer as necessary to enable production of Product in acceptable quality and quantity and provide such other assistance to assure an efficient and smooth transfer of the manufacturing processes for the Product. Such information will be provided only to the Second Source Manufacturer and only under strict confidentiality.